CareFusion 303, Alaris Pump Module, Model 8100 Recalled due to Potential for Infusion to Stop

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Risk Managers are informed by the FDA that CareFusion 303, Alaris Pump Module, Model 8100 is recalled because there is a potential for the pump to malfunction and stop infusion leading to life-threatening consequences.

Background of CareFusion 303, Alaris Pump Module, Model 8100

Alaris Pump Module, Model 8100, by CareFusion 303 Inc, is used for the delivery of medications and fluids to patients through various acceptable routes of administration (i.e. intravenous, epidural, etc.). It is used for newborns, children and adults. FDA Alert on CareFusion 303, Alaris Pump Module, Model 8100

FDA’s reason for the recall is that the pump module door keypad overlay may become loose, or even separate from the door assembly. This can lead to keypad malfunction causing the infusion to stop. The consequences can be life-threatening.

The FDA classified this recall as Class I, meaning use of the products included in the recall may cause serious injuries or death.

Recommendation on CareFusion 303, Alaris Pump Module, Model 8100

“Starting on July 20, 2102, each affected customer and distributor received an URGENT: Medical Device Recall Notification letter, FAQs, Summary of Affected Units and Response Card by overnight courier service. Customers were asked to visually examine the pump module keypad overlay for obvious signs of overlay separation. (See photo of an example of a separating keypad overlay in link below by locating CareFusion’s URGENT: Medical Device Recall Notification letter. The problem may look different on different pump modules). See a listing of affected serial numbers in the FDA Recall Notice.

Carefusion informed customers that they will contact their facility by phone within 60 days of receiving the letter to schedule a visit to replace the door assembly on their affected pump module.”

Contacting the FDA to report cases with CareFusion 303, Alaris Pump Module, Model 8100

In case of detection of adverse events or side effects related to the use of CareFusion 303, Alaris Pump Module, Model 8100, healthcare professionals and patients should report it to the FDA’s MedWatch Safety Information and Adverse Event Reporting program through any of the following ways:

The report can be completed and submitted Online at: www.fda.gov/MedWatch/report.htm

The form can be downloaded or requested by calling 1-800-332-1088, then completed and returned on the address indicated on the form

The completed form can be faxed to:  1-800-FDA-0178

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